NLTX - Neoleukin drops on FDA clinical hold letter related to IND for cancer immunotherapy

Neoleukin Therapeutics (NLTX) drops ~20% in premarket trading after receiving a clinical hold from the FDA related to its Investigational New Drug ((IND)) application to start a Phase 1 program of its immunotherapeutic candidate, NL-201.The FDA has asked the company to develop a new assay that more precisely measures the amount of protein being administered, and with the help of this assay demonstrate that dose and administration procedures will accurately deliver the intended dose of NL-201.The agency also has additional requests related to the amendment of the IND.Neoleukin says it will be able to develop the requested assay and respond within the next several months.NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer cells without any bias toward cells expressing the alpha receptor subunit.

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Neoleukin drops on FDA clinical hold letter related to IND for cancer immunotherapy